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Director, Gene Therapy Clinical Manufacturing


Durham, NC
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Job Details


The Director of Gene Therapy Clinical Manufacturing is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

The successful candidate will manage clinical manufacturing operations personnel at the Chapel Hill facility. Additionally, the director will be responsible for tech transfer of processes into the facility, manufacturing support functions, and facility suitability.


+ Responsible for leading team to manufacture early phase gene therapy clinical supplies including direct manufacturing operations and support functions.

+ Oversight of technology transfer efforts into the gene therapy clinical manufacturing facility.

+ Direct reporting and career development responsibility for 4-6 direct reports and 10-15 next level operations team.

+ Lead team in troubleshooting process related issues in collaboration with operations group and lab scientists.

+ Strong bioprocess knowledge required to provide guidance or direction for team and effectively communicate and/or escalate process related issues.

+ Coordination of team activities and scheduling of operations with other area managers.

+ Cross functional collaboration with BRD lab scientists, Quality Unit, site and network manufacturing facilities, and Engineering on interdepartmental and cross site initiatives.

+ Responsible for facility preparation and product changeovers.

Responsible for all facility related investigations and audits.


+ BS or MS in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent)

+ 10+ years experience in biologics manufacturing or clinical manufacturing, process development, or technology transfer required. Experience in gene therapy is desired.

+ Management experience in a cGMP environment is required.

+ Demonstrated capability to work across functional areas such as development, maintenance, quality and regulatory.

+ Good communication skills, verbal and written, are required.

Working knowledge of computers and associated applications such as MS Word, Excel, and PowerPoint are recommended.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**Other Job Details:**

+ **Last Date to Apply for Job:** March 1, 2018

+ Eligible for Relocation Package: yesEligible for Employee Referral Bonus: yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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